Policy & Regulation
Alzamend Neuro Initiates Phase I First-in-Human Clinical Trial for AL001 for Dementia Related to Alzheimer's Disease
14 September 2021 - - The first group of healthy participants have been dosed in a six-month Phase I relative bioavailability study for AL001 for dementia related to Alzheimer's disease, US-based biopharmaceutical company Alzamend Neuro, Inc. (NASDAQ: ALZN) said.

The Phase I first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in future studies.

AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's disease.

The Phase I study will investigate the pharmacokinetics (the movement of drug through the body) of lithium following a single dose of AL001 compared to a typical single dose of a marketed 300 mg immediate-release lithium carbonate capsule in healthy male and female subjects.

The lithium and salicylate components of AL001 will be given within the amounts already approved for use in patients.

The purpose of the research study is to test the safety, tolerability, and bioavailability (how much and when drug gets in the body) of the study drug, AL001, compared to the currently marketed formulation of the comparator, lithium carbonate.

This is expected to ascertain what AL001 doses should be given, and how often, in subsequent Phase 2 safety and efficacy trials involving Alzheimer's disease patients. At least 24 healthy male and female human subjects will complete the Phase I trial.

AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer's disease and psychiatric disorders.

Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.
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